Surgical Staple

ABSTRACT

A surgical staple comprising a first deformable leg, a second deformable leg and a backspan having first and second transverse portions spaced apart to create a gap therebetween. The backspan further includes a third transverse portion spaced distally from the first and second transverse portions and distally of the gap. A first non-linear backspan portion extends between the first transverse portion and the first end portion of the third transverse portion and a second non-linear backspan portion extends between the second transverse portion and the second end portion of the third transverse portion.

This application claims priority to provisional application Ser. No.61/235,372, filed Aug. 20, 2009, the entire contents of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a surgical staple, and moreparticularly, to a surgical staple configured to accommodate varyingtissue compression.

2. Background of Related Art

Surgical staples are highly specialized staples that can be employedduring a variety of medical procedures (e.g., surgery). Closing skinwounds, anastomosing bowels, and excising portions of a lung are just afew of the many different types of medical procedures where surgicalstaples can be employed.

Clinicians have turned to surgical staplers and the surgical staplesassociated therewith as popular alternatives to traditional suturingmethods in the medical environment. Incorporating a surgical staplerinto a procedure allows a clinician to quickly and easily close tissue.

Current stapling technology can employ multiple surgical staples havingfirst and second legs, and a backspan. As is the case with mostconventional surgical staples, when the surgical staple is deployed, thesurgical staple penetrates tissue, creating a hole(s) and anaccompanying staple line. Located along the staple line and between thelegs of the surgical staple is captured tissue. The captured and nowtransected tissue becomes hemostatic, which results in minimal leakageof bodily fluids around the transected tissue area. However, due tostapling through variable thicknesses causing over-compression in someareas or pressure changes in the body and/or other normal body processes(e.g., healing), tissue that is not captured between the legs of thesurgical staples may stretch and pull away from the legs of the surgicalstaples which may cause stress on the hole created by the surgicalstaples and/or form a path in which bodily fluids may leak, both ofwhich, in turn, can impede the healing process.

Therefore, a surgical staple that allows for relative motion of thestaple backspan after the surgical staple has been deployed into tissuemay be helpful in accommodating the change in tissue, especially in thedirection allowing relaxation of strain.

SUMMARY

The present disclosure advantageously provides a staple with a backspanconfigured and dimensioned to spring back in an amount proportional tothe amount of tissue compression after staple application, therebyadvantageously relaxing and reducing the risk of tissue tearing incertain procedures. Thus, the overall stiffness of the staple applied totissue is reduced.

More specifically, in accordance with one aspect of the presentdisclosure, a surgical staple is provided having a first deformable leghaving a first proximal portion and a first distal portion having afirst tissue penetrating tip, and a second deformable leg having asecond proximal portion and a second distal portion having a secondtissue penetrating tip. A backspan has a first transverse portionextending from the first proximal portion of the first leg and a secondtransverse portion extending from the second proximal portion of thesecond leg. The first and second transverse portions are spaced apart tocreate a gap therebetween. The backspan further includes a thirdtransverse portion having a first end portion and a second end portion,wherein the third transverse portion is spaced distally from the firstand second transverse portions and distally of the gap. A firstnon-linear backspan portion extends between the first transverse portionand the first end portion of the third transverse portion and a secondnon-linear backspan portion extends between the second transverseportion and the second end portion of the third transverse portion.

In one embodiment, the first and second transverse portions lie insubstantially the same plane. The third transverse portion in preferredembodiments is substantially parallel to the first and second transverseportions. In one embodiment, each of the first and second non linearbackspan portions comprises a somewhat S-shaped configuration withsubstantially straight portions and substantially 90 degree bends.

In accordance with another aspect of the disclosure, a surgical stapleis provided comprising a first deformable leg having a first proximalportion and a first distal portion having a first tissue penetratingtip, a second deformable leg having a second proximal portion and asecond distal portion having a second tissue penetrating tip, and abackspan having a first region and a second region. The first region hasa first transverse portion extending inwardly from a proximal portion ofthe first leg toward the second leg, bending distally toward the firstpenetrating tip of the first leg, bending back toward the first leg,bending again toward a distal portion of the first leg and bendinginwardly toward the second leg. The second region of the backspan has asecond transverse portion extending inwardly from a proximal portion ofthe second leg toward the first leg, bending distally toward the secondpenetrating tip of the second leg, bending back toward the second leg,bending again toward a distal portion of the second leg and bendinginwardly toward the first leg.

Preferably, at least one of the bends of the first and second legs is atapproximately ninety degrees. In a preferred embodiment, the first andsecond transverse portions of the backspan have a gap formedtherebetween.

The present disclosure also provides a staple cartridge for use with asurgical stapler comprising a plurality of surgical staples supported ina spaced relation to each other wherein each of the surgical staplesincludes a first deformable leg, a second deformable leg, and a backspanjoining the first and second legs. The backspan has a first portionextending from the first leg and a second portion extending from thesecond leg, wherein the first and second portions of the staple backspanare spaced apart to form a gap therebetween. A third portion of thestaple backspan is positioned distal of the first and second portions. Aplurality of staple pushers are movable into contact with the thirdportion of the staple backspan.

In preferred embodiments, the third portion of the backspan issubstantially parallel to the first and second portions of the backspan.

In another aspect, the present disclosure provides a method for applyinga surgical staple to tissue comprising:

providing a staple having a first deformable leg member having a firstportion of a staple backspan extending therefrom and a second deformableleg member having a second portion of the staple backspan extendingtherefrom, the second portion of the staple backspan spaced apart fromthe first portion of the staple backspan to form a gap therebetween, anda third portion of the staple backspan positioned distal of the firstand second portions; and

advancing a pusher through the gap between the first and second portionsof the staple backspan and into contact with the third portion toadvance the staple legs through tissue and into contact with an anvilfor deformation thereof.

In an embodiment, the step of advancing the pusher through the gapcauses a projection of the pusher to contact the third portion and aftera predetermined maximum movement or force of the staple is achievedduring application of the staple, surface portions of the pusher contactshoulders of the staple to avoid over-straining of the first and secondportions of the staple backspan.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed device are describedherein with reference to the drawings, wherein:

FIG. 1 is a perspective view of one type of surgical instrumentutilizing the surgical staples of the present disclosure;

FIG. 2 is an exploded view of the cartridge assembly of the instrumentof FIG. 1 having four rows of staples;

FIG. 3 is an enlarged view of the staple and staple pusher of thepresent disclosure;

FIG. 4 is a side view of the surgical staple in the unformed condition;and

FIG. 5 is a side view in partial cross-section of the staple of FIG. 4being applied to tissue; and

FIG. 6 is a view similar to FIG. 5 showing the movement of the backspanin response to the force of tissue.

DETAILED DESCRIPTION

In the present disclosure, it is envisioned that the staples disclosedherein may be utilized with various stapling instruments, such ascircular anastomosis staplers, linear staplers, transverse staplers,including open and laparoscopic/endoscopic staplers. FIG. 1 provides byway of example one type of surgical instrument that can be used to applythe surgical staples of the present disclosure and FIG. 2 illustratesthe cartridge of the stapler 10 that contains the surgical staples. Theinstrument 10 is an open surgical linear stapler such as that disclosedin U.S. Pat. No. 7,140,527, the entire contents of which areincorporated herein by reference. With reference to FIG. 1, the stapler10 has a cartridge assembly 12, an anvil assembly 14 and a slidable knob26 to advance cam bars to contact staple pushers to advance the staplesfrom the cartridge assembly 12 into contact with an anvil of the anvilassembly 14.

In the drawings and in the description which follows, the term“proximal”, as is traditional, will refer to the end of the surgicaldevice or instrument of the present disclosure which is closer to theoperator, while the term “distal” will refer to the end of the device orinstrument which is further from the operator.

Referring to FIG. 2, surgical stapling cartridge assembly 12 isillustrated having a cartridge 16 having a plurality of staple slots 22with a knife slot 24 in between to accommodate distal movement of aknife to cut tissue between the staple rows. In the cartridge 16 shown,there are two parallel rows of staple slots 22 on each side of the knifeslot 24; however, it should be appreciated that a different number ofstaple slots could be provided to accommodate different rowconfigurations of staples. For example, one row of staples (and stapleslots) or three rows can be provided on each side of the knife slot. Thestaples are designated generally by reference numeral 30 and the staplepushers are designated generally by reference numeral 80. Details of theoperation of the stapler 10, e.g. clamping of the cartridge and anvilassemblies and advancement of the firing knob to fire staples, aredisclosed in U.S. Pat. No. 7,140,527, incorporated by reference above.

Referring to FIGS. 3 and 4, the staple 30 will now be described. Thestaple is preferably composed of a stainless steel wire of circularcross-section, although other materials and wire shapes arecontemplated. The staple 30 comprises in general a pair of legs 32, 42joined by a backspan 50 having first and second spaced apart proximaltransverse portions 52 and 62 and a third transverse region 59 spaceddistally of the first and second transverse portions 52, 62 andaccessible by a staple pusher 80 described below passing through thespace (gap) 70 between the first and second transverse regions 52, 62.

More specifically, staple 30 has a first deformable leg 32 and a seconddeformable leg 42. The backspan 50 is divided for convenience ofdescription into first region 51 associated with staple leg 32 andsecond region 61 associated with staple leg 42. Preferably, the backspanregions 51 and 61 are integral and integral with the staple legs 32, 42so they are formed of a single wire. Each leg 32, 42 terminates in adistal tip 34, 44, respectively, configured for penetrating tissue. Theproximal portion 35 of first leg 32 transitions into the firsttransverse backspan portion 52 of backspan 50. Similarly, the proximalportion 45 of second leg 42 transitions into the second transversebackspan portion 62 of backspan 50. First and second backspan portions52, 62 are part of the aforementioned backspan regions 51, 61,respectively. Preferably, the staple legs 32, 42 extend substantiallyperpendicular to their respective backspan portion and substantiallyparallel to one another. However, it is also contemplated that the legsconverge or diverge so that they extend from the backspan portion at adifferent angle than the approximate 90 degrees shown.

First transverse backspan portion 52 extends inwardly toward second leg42, then extends distally at portion 54 toward the distal tip 34 of leg32, then extends inwardly back toward the first leg 32 at portion 55,then extends distally at portion 56 and then inwardly toward second leg42 at portion 57. These portions can be considered part of firstbackspan region 51.

The second backspan region 61 of the backspan 50 is the mirror image ofthe first backspan region 51. More specifically, second transversebackspan portion 62 extends inwardly toward first leg 32, then extendsdistally at portion 64 toward the distal tip 44 of leg 42, then extendsinwardly back toward the second leg 42 at portion 65, then extendsdistally at portion 66, then inwardly toward first leg 32 at portion 67.These portions can be considered part of second backspan region 61.

Stated another way, the first backspan region 51 has a first transverseportion 52 connected by a somewhat S-shaped region to portion 57 of thethird transverse region 59 and second backspan region 61 has a secondtransverse portion 62 connected by a somewhat S-shaped region to portion67 of the third transverse region 59. Portions 57 and 67 are preferablyjoined so the third transverse region 59 is substantially linear andcontinuous as shown. First transverse portion 52 and second transverseregion 62 are preferably substantially linear and spaced apart forming agap 70 therebetween. This gap 70 allows access of the staple pusher 80to the third transverse region 59 as described below.

The bends at the various portions of the first and second backspanregions 51, 61 are preferably about 90 degrees with substantially linearportions formed, thus having a somewhat S-shape with substantiallylinear portions and approximately 90 degree angles. Regions with curvesand/or regions joined by different angles are also contemplated.

The pushers 80 of the cartridge assembly 12 are positioned adjacentstaple slots 22 and configured to advance an individual staple 30 intoengagement with the anvil of anvil assembly 14. A plurality of cam bars(not shown) are contained within the cartridge assembly 12 and aremovable distally by the sliding knob 26. As the cam bars engage angledinner surface 81 of staple pusher 80, pusher 80 is advanced toward thestaple slot 22 to advance the staple 30 from the cartridge 16 and intocontact with an anvil wherein the staple legs 32, 42 contact and aredeformed by anvil pockets to bend toward each other. The projectingfinger 82 of pusher 80 passes through the gap 70 between the first andsecond transverse portions 52, 62 of staple 30 and into contact with thethird transverse region 59, preferably in a substantially central regionthereof as shown in FIG. 5. By contacting the center region rather thanthe shoulders, i.e., at the backspan region adjacent the transition tothe staple legs, the staple 30 is placed in tissue with the backspan 50positioned to compress the tissue and allow for subsequent flexing. Thatis, as the tissue expands or stretches after application of the staple30, the backspan 50 flexes to accommodate the tissue movement This isshown for example by comparing FIGS. 5 and 6.

FIG. 5 shows application of the staple 30 by staple pusher 80. Thepusher 80 is configured such that after a maximum predetermined amountof movement/force applied by finger 82 to region 59, contact of surfaces83 a, 83 b of the pusher 80 with the shoulders, i.e. portions oftransverse portions 52, 62 of backspan 30 adjacent legs 32, 42, takesplace thus avoiding over-straining of the flexure elements during stapleapplication.

FIG. 6 shows flexing of the backspan 50 by the tissue T as the backspanmoves proximally after the staple application. More specifically, due tothe bending regions of the backspan 50, the third transverse region 59can flex toward the first and second transverse portions 52, 62,respectively, to allow for tissue expansion (push back of tissue). Firstand second transverse portions 52, 62 can also flex in a direction awayfrom the formed staples leg 32, 42, providing room for tissuestretching/expansion. Thus, the compliancy/springiness of the backspan50 of the staple 30 accommodates tissue push back on the staple, Inother words, the stiffness of the staple is determined mostly by itsmultiple flexure spring-like backspan, rather than its legs, as thestaple springs back by an amount determined by and proportional to theamount of tissue compression, thereby relaxing and reducing the risk oftearing in certain applications as it can apply a nearer to constantforce/pressure on tissue.

While several embodiments of the disclosure have been shown in thedrawings and/or discussed herein, it is not intended that the disclosurebe limited thereto, as it is intended that the disclosure be as broad inscope as the art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

1. A surgical staple, comprising: a first deformable leg having a firstproximal portion and a first distal portion having a first tissuepenetrating tip; a second deformable leg having a second proximalportion and a second distal portion having a second tissue penetratingtip; and a backspan having a first transverse portion extending from thefirst proximal portion of the first leg and a second transverse portionextending from the second proximal portion of the second leg, the firstand second transverse portions spaced apart to create a gaptherebetween, the backspan further including a third transverse portionhaving a first end portion and a second end portion, the thirdtransverse portion spaced distally from the first and second transverseportions and distally of the gap, and a first non-linear backspanportion extending between the first transverse portion and the first endportion of the third transverse portion and a second non-linear backspanportion extending between the second transverse portion and the secondend portion of the third transverse portion.
 2. The surgical stapleaccording to claim 1, wherein the first and second transverse portionslie in substantially the same plane.
 3. The surgical staple according toclaim 1, wherein the third transverse portion is substantially parallelto the first transverse portion.
 4. The surgical staple according toclaim 1, wherein the first leg member extends substantiallyperpendicular to the first transverse portion and the second leg memberextends substantially perpendicular to the second transverse portion. 5.The surgical staple according to claim 1, wherein each of the first andsecond non-linear backspan portions comprises a somewhat S-shapedconfiguration with substantially straight portions.
 6. The surgicalstaple according to claim 1, wherein the non-linear backspan portionseach comprise two distally extending regions joined by a transverseregion.
 7. The surgical staple according to claim 1, wherein the firstand second legs are bent toward each other by contact with an anvilpocket.
 8. A surgical staple, comprising: a first deformable leg havinga first proximal portion and a first distal portion having a firsttissue penetrating tip; a second deformable leg having a second proximalportion and a second distal portion having a second tissue penetratingtip; and a backspan having a first region and a second region, the firstregion having a first transverse portion extending inwardly from aproximal portion of the first leg toward the second leg, bendingdistally toward the first penetrating tip of the first leg, bending backtoward the first leg, bending again toward a distal portion of the firstleg and bending inwardly toward the second leg, the second region of thebackspan having a second transverse portion extending inwardly from aproximal portion of the second leg toward the first leg, bendingdistally toward the second penetrating tip of the second leg, bendingback toward the second leg, bending again toward a distal portion of thesecond leg and bending inwardly toward the first leg.
 9. The surgicalstaple according to claim 8, wherein at least one of the bends of thefirst and second legs are at approximately ninety degrees.
 10. Thesurgical staple according to claim 9, wherein the first and secondtransverse portions of the backspan have a gap formed therebetween. 11.A staple cartridge for use with a surgical stapler, the staple cartridgecomprising: a plurality of surgical staples supported in a spacedrelation to each other, each of the surgical staples including: a firstdeformable leg; a second deformable leg, and a backspan, the first andsecond legs extending from the backspan, the backspan having a firstportion extending from the first leg and a second portion extending fromthe second leg, the first and second portions joining the first andsecond legs, wherein the first and second portions of the staplebackspan are spaced apart to form a gap therebetween, and a thirdportion of the staple backspan is positioned distal of the first andsecond portions.
 12. The surgical staple according to claim 10, whereinthe third portion of the backspan is substantially parallel to the firstportion of the backspan.
 13. The surgical staple according to claim 11,wherein the third portion of the backspan is substantially parallel tothe second portion of the backspan.
 14. The surgical staple according toclaim 13, wherein the third portion of the backspan is substantiallyparallel to the first portion of the backspan.
 15. The surgical stapleaccording to claim 11, wherein the first leg member and the second legmember each include a tissue penetrating tip.
 16. A method for applyinga surgical staple to tissue comprising: providing a staple having afirst deformable leg member having a first portion of a staple backspanextending therefrom and a second deformable leg member having a secondportion of the staple backspan extending therefrom, the second portionof the staple backspan spaced apart from the first portion of the staplebackspan to form a gap therebetween, and a third portion of the staplebackspan positioned distal of the first and second portions; andadvancing a pusher through the gap between the first and second portionsof the staple backspan and into contact with the third portion toadvance the staple legs through tissue and into contact with an anvilfor deformation thereof.
 17. The method according to claim 16, whereinthe step of advancing the pusher through the gap causes a projection ofthe pusher to contact the third portion and after a predeterminedmaximum movement or force of the staple is achieved during applicationof the staple, surface portions of the pusher contact shoulders of thestaple to avoid over-straining of the first and second portions of thestaple backspan.
 18. The method according to claim 16, wherein the stepof providing a staple includes the step of providing the staple whereinthe first leg member and the second leg member are substantiallyparallel in the unformed condition.
 19. The method according to claim18, wherein the step of providing a staple includes the step ofproviding the staple wherein the third portion of the backspan issubstantially parallel to the first and second portions of the backspan.